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Keywords: Director, US Regulatory Affairs Strategy, Location: Basking Ridge, NJ

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Director, US Regulatory Affairs Strategy

Experience Qualifications 7 or More Years in the pharmaceutical industry 4 or More Years in regulatory affairs, NDA, sNDA, BLA... with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support...

Company: Daiichi Sankyo
Location: Basking Ridge, NJ
Posted Date: 10 Nov 2024

Director Global Regulatory Affairs

Affairs Knowledge of IND, NDA/BLA submission experience Experience with regulatory submission strategy globally... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development...

Company: Daiichi Sankyo
Location: Basking Ridge, NJ
Posted Date: 19 Dec 2024

Senior Director, US Regulatory Affairs Alliance Team Lead

and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs... assigned to alliance assets for operational matters. Responsibilities: Develop and implement US regulatory strategy...

Company: Daiichi Sankyo
Location: Basking Ridge, NJ
Posted Date: 14 Nov 2024

Associate Director, Technical Lead, Global Applications & Services, DX

to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational...

Company: Daiichi Sankyo
Location: Basking Ridge, NJ
Posted Date: 14 Dec 2024

Director, PV Strategic Partner Management

within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate... Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service...

Company: Daiichi Sankyo
Location: Basking Ridge, NJ
Posted Date: 16 Nov 2024